Kornimate/medical-research-clean huggingface dataset:
optimization of exhaled biomarker collection and analysis

Conditions: Respiratory Disease; Healthy

Summary: this is an exploratory study designed to optimize, standardize, and validate novel breath biomarkers; there are no objective endpoints. the goal of this study is to generate pilot data to be used to generate hypothesis-driven studies.

exhaled breath has three fractions - gaseous breath, volatile breath, and breath condensate. biomarkers have been identified in each of these fractions and non-invasive collection methods have been developed. exhaled breath can be safely and easily performed in all patient populations, including neonatal children and the elderly. we have shown that relative to normal controls, condensed exhalates obtained from asthmatic subjects reproducibly contain elevated concentrations of oxides of nitrogen and are more acidic (having hydrogen ion concentrations two to three log orders higher). we wish to extend these studies across all breath fractions and other lung diseases and respiratory processes including viral upper respiratory tract infections, cystic fibrosis, pneumonia, pulmonary hypertension, bronchiolitis obliterans, chronic obstructive pulmonary disease, tracheostomized patients and cigarette smokers. through this study extension, we will obtain pilot data/preliminary information about the potential utility of this new technique to non-invasively evaluate disease status in various respiratory diseases. we also wish to obtain data regarding specificity by evaluating the exhaled breath obtained from patients with non-respiratory illnesses, such as, but not limited to diabetes, gastroenteritis, and various inflammatory disorders. we think it is likely that the exhaled biomarkers reflect underlying airway inflammation and infection. following informed consent, exhaled breath will be passively collected from subjects during quiet oral breathing through a simple mouthpiece or mask. exhaled breath will be diverted into a collection device, which may include a bag, tube, or other device with minimal resistance. the collection process, including completing forms, will not exceed 30 minutes. subjects may be asked to provide several specimens during the course of their inpatient stay or clinic visit to obtain longitudinal data. at no time will the patients be breathing anything other than ambient air with or without oxygen enrichment as clinically indicated. inhaled air will not be manipulated. exhaled breath collection technique is completely comfortable, causing neither discomfort nor fatigue.

Eligibility criteria:
inclusion criteria: * study sample will consist of individuals aged 4-110 with a diagnosis of acute or chronic respiratory disorders, or metabolic or systemic conditions involving diffuse inflammation, or normal subjects with no pulmonary disease. exclusion criteria: * subjects that are unable or unwilling to cooperate with specimen collection.
endocrine regulation of energy and fluid supplies in alcoholic patients

Conditions: Alcoholism

Summary: this study is about the endocrine regulation of energy and fluid supplies in alcoholic patients. a large proportion of energy and fluid is supplied by alcohol beverages in alcoholic patients. in this study, we evaluated the importance of these supplies with a detailed questionnaire, a nutrition software that evaluated the importance of each macro- and micronutrients and correlated these values with several hormones such as leptin, insulin, cortisol, ghrelin, and pyy involved in the regulation of energy balance or avp involved in the regulation of plasma osmolality

this study was conducted in a stepwise manner : study of the energy supplies first, of water supplies next. interviews and samples were performed or collected at two times of alcohol withdrawal to evaluate the possibility of parallel changes in craving for alcohol, supplies and endocrine function.

Eligibility criteria:
inclusion criteria: * alcoholic patients still under the effect of alcohol at entry exclusion criteria: * other type of addiction

Keywords: alcoholism nutrition craving energy supplies water supplies
cerebrospinal fluid (csf) pharmacokinetics of antimicrobials in children

Conditions: Infections

Summary: the purpose of this study is to learn more about antimicrobials, especially drug levels in the csf that would normally be used in young children as part of standard care. these drugs are approved by the food and drug administration (fda) for treating infections. they are used extensively in children in the united states, but they have not been extensively studied in children or babies. the investigators do not have very much information on how children and babies handle these drugs; that is, how long it takes for the drugs to be removed from the blood circulation and to pass out of the body and how much goes into the central nervous system. the investigators also do not have good information to guide how often the investigators should give the drugs to children and babies to get the maximum effect on infections with the minimum amount of drug. thus, the investigators will collect more information about how these drugs should be used in children and babies by doing this drug levels research study.


Eligibility criteria:
inclusion criteria: * children receiving antimicrobial agents and having cerebrospinal fluid collected as part of standard of care exclusion criteria: * lack of consent

Keywords: infections in children
method of genetic analysis in genodermatoses

Conditions: Genodermatosis; Rare Genetic Disease With Cutaneous Expression

Summary: the goal of the study is to develop a method of genetic diagnosis in two stages, by mendelioma then by genome and transcriptome on fibroblast culture, in genodermatoses and rare diseases with cutaneous expression in the child.

interventional multicenter prospective study. patients will be examined by a dermatologist to describe and identify the various skin lesions collaboration with the geneticist team: clinical examination for relevant cases patient records will be consulted. relevant medical information, biological examinations and other complementary examinations will be studied. a blood sample (10 ml in edta tube) will be collected from the patient and his/her parents to store dna for mediome and genome. a written parental and child consent (if age-appropriate) will be obtained and a study information sheet will be signed. they will also sign the usual genetic consent request for mendeliome, genome and transcriptome on culture of fibroblasts. a 4 mm punch skin biopsy (healthy or damaged depending on phenotype and indication) will be performed according to the standard technique. the fibroblast culture will be performed routinely by the genetics center transcriptome will be done according to the processes set up at the genetics center mendeliome analysis * allow the analysis of 4000 rare disease genes * will be performed according to routine analyzes of the genetics lab * uses the highlander tools (web) * use of de novo filters, autosomal recessive, heterozygous compound, x linked, strong variant (lof and canonical splice sites) * use of rarer filters: exomic or gene deletion, splicing (+/- 12 base pairs around exons) * in unexplained severe cases, a genome supplemented with the 10xgenomics method and a transcriptome of fibroblasts will be realized. this double strategy afford to get a genome of high interpretative quality. genome analysis by the 10xgenomics method (https://www.10xgenomics.com ) * this method allows us to deconvolate haplotypes and allows the analysis of 16,000 other complementary genes and to obtain precisely defined structural variants. * the transcriptome will better assess the genomic effects on gene expression. * the genome and transcriptome will also assess the presence of deep intron mutations and their effect on splicing, and will be a sustainable resource for other long-term projects (analysis of non-coding regions, micrornas, etc.)

Eligibility criteria:
inclusion criteria: * children between 0 to 18 years old * presence of dermatological symptoms suggesting genodermatosis * presence of systemic symptoms in an undiagnosed patient associated with dermatological manifestations suggestive of a more rare genetic disorder with cutaneous expression exclusion criteria: * mosaicism * neurofibromatosis, all type * tuberous sclerosis * ichthyosis vulgaris * suspicion of somatic impairment (giant nevus)

Keywords: genodermatosis genetic children
efficacy and safety of rivastigmine transdermal patch in patients with mild to moderate alzheimer's disease

Conditions: Alzheimer's Disease

Summary: the purpose of this study was to investigate the 5cm\^2 and 10cm\^2 doses of rivastigmine transdermal patch in terms of efficacy and safety in patients with probable alzheimer's disease (mmse \[mini mental state examination\] 10-20). a 52-week extension phase evaluated the safety and tolerability of long-term treatment by rivastigmine transdermal patch in patients with probable alzheimer's disease (ad).

patients were randomly assigned in a double-blind manner to one of the 3 treatment arms (placebo, rivastigmine 5 cm\^2 and rivastigmine 10 cm\^2) in a ratio of 1:1:1. during the double-blind treatment phase, patients entered a 16-week titration period followed by an 8-week maintenance period. during the open-label extension phase, all patients started treatment with a 2.5 cm\^2 patch and the dose was increased to 10 cm\^2 over a 16-week titration period, followed by a maintenance period of 36 weeks.

Eligibility criteria:
inclusion criteria: * a diagnosis of dementia of the alzheimer's type according to the dsm-iv criteria * a clinical diagnosis of probable ad according to nincds/adrda criteria * an mmse score of \> or = 10 and \< or = 20 exclusion criteria: * a current dsm-iv diagnosis of major depression * taken rivastigmine in the past * a score of \> 5 on the modified hachinski ischemic scale (mhis) other protocol-defined inclusion/exclusion criteria may apply other protocol-defined inclusion/exclusion criteria may apply extension phase eligibility criteria inclusion criteria: * patients who have completed the double-blind treatment phase on study medication exclusion criteria * patients who have any important protocol deviations until the completion of the double-blind treatment phase

Keywords: rivastigmine，alzheimer's disease, transdermal patch
ondansetron for the treatment of cocaine dependence - 1

Conditions: Cocaine-Related Disorders; Drug Administration Schedule

Summary: the purpose of this study is to assess the efficacy and safety of ondansetron to reduce cocaine use in subjects with cocaine dependence.

double-blind, placebo-controlled, 4-parallel group design to assess the efficacy and safety of 3 wide range doses of ondansetron to reduce cocaine use in subjects with cocaine dependence and to determine the optimal dose of ondansetron.

Eligibility criteria:
inclusion criteria: male/female, at least 18 yrs of age; dsm-4 diagnosis of cocaine dependence; seeking treatment for cocaine dependence; have ability to understand, having understood and provide written consent; females of child bearing potential that use accepted method of birth control exclusion criteria: additional criteria available during screening at the site.

Keywords: cocaine dependence
can a novel manual therapy technique help relieve stress? assessing effects of primal reflex release on the body's stress response

Conditions: Psychological Stress

Summary: stress, when left unmanaged, can have detrimental effects on both physical and mental health, contributing to conditions such as high blood pressure, anxiety, and even cardiovascular disease. effective stress management therapies may help maintain overall well-being and reduce the risk of long-term health complications. the primal reflex release technique (prrt) is a novel manual therapy that may reduce markers related to stress such as heart rate variability (hrv) and patient-reported outcomes (pros). therefore, the purpose of this study is to elucidate the potential for prrt to improve hrv and pros.

this randomized, controlled experimental intervention study evaluates acute impacts of a reflex-targeted manual therapy called primal reflex release technique (prrt) on cardiovascular indices of stress and sympathetic tone. after consenting and baseline characteristics, subjects are allocated to receive either the prrt or the control condition. continuous electrocardiography (ecg) and impedance cardiography (icg) monitoring will be used to track heart rate variability (hrv) changes across three phases: 1. pre-intervention during a 5-minute video of aquatic nature scenes to establish resting baseline 2. 5 minutes of a practitioner administering targeted spinal manipulation prrt protocol in the treatment group to stimulate innate protective reflexes or continued relaxation video viewing for control group 3. post-intervention repeat of the standardized video to assess changes after prrt session without ongoing manipulation the prrt targets precise anatomical locations and neural pathways including stimulating facial muscles, upper spinal reflexes and traction of the suboccipital muscles. brief, reversible sensations will occur without expected harm or lasting effects. psychological state assessed via paper mood scales pre/post tracks subjective stress correlates. analysis using linear mixed effects models contrast whether indices of cardiovascular reactivity and psychological responses shift acutely with prrt versus control video. findings could provide physiological validation for integration as stress-alleviating treatment.

Eligibility criteria:
inclusion criteria: * subject can refrain from caffeinated beverages in the 6 hours prior to data collection * subject is not currently taking any beta blockers * subject is comfortable with a manual therapy technique where the clinician touches your face and head exclusion criteria: * subject has had caffeine within 6 hours * subject is currently taking any beta blockers
observational cohort study of chronic low back pain

Conditions: Back Pain Lower Back Chronic

Summary: this research study is being done to understand the outcomes of back pain treatment and costs associated with it in an academic hospital outpatient setting. the investigators will conduct a prospective observational cohort study to assess the clinical outcomes and utilization of health care services of 175 osher clinical center (occ) patients with chronic low back pain (clbp) compared with a comparison group of 175 non-occ clbp patients treated within brigham and women's hospital. outcomes will include assessment of functional status, symptom relief, satisfaction with care, health-related quality of life, and worker productivity, and will be measured in person at baseline, and by phone by an interviewer blinded to cohort group at 3, 6, and 12 months.


Eligibility criteria:
inclusion criteria: * 3 months or more of chronic low back pain or 6 months or more of intermittent low back pain or * having at least one of a list of icd-9 diagnostic codes for uncomplicated low back pain * having two or more visits for back pain within the past two years; one of these visits must have happened within the past year (as a screening marker of chronicity) exclusion criteria: * under the age of 21 * unable to understand english * have complicated low back pain (e.g. history of back pain related to cancer, fracture, or infection) * unable to participate in the phone follow-up for the next one-year period.

Keywords: complementary and alternative medicine (cam)
impact of extracorporeal phototherapy (ecp) on auxiliary follicular t-lymphocytes and circulating b-lymphocytes during chronic antibody-mediated rejection in kidney transplantation.

Conditions: Kidney Transplantation

Summary: chronic antibody-mediated rejection (cabmr) is the leading cause of late kidney transplant loss (after 1 year of kidney transplantation). its therapeutic management is poorly codified and there is currently no treatment referring. extracorporeal phototherapy (ecp) is a therapeutic apheresis that involves purifying mononucleated cells in the blood, exposing them to ultraviolet a (uva) and re-injecting them to the patient. this treatment is used as common care in the first line as part of the treatment of cutaneous t lymphoma and in the second line as part of the graft versus host reaction after bone marrow allograft. the mechanisms underlying the action of the ecp are not well known. they are mediated by the reinjection of cells exposed to uva which enter apoptosis and induce immunomodulation. recent work during cabmr shows that tfh lymphocytes, the maturing population of b lymphocytes, are deregulated and activated. the hypothesis is that ecp can modulate t follicular helper (tfh) lymphocytes during cabmr.


Eligibility criteria:
inclusion criteria: * ecp treatment decision based on transplant team habits (care management) * age ≥ 18 years * affiliation to a french social security scheme * kidney transplant at least 6 months prior to inclusion * cabmr proven by a renal graft biopsy less than 3 months and meeting the following histological criteria: * allograft glomerulopathy (cg\>0, and maximum score cg2) or intimal fibrosis * c4d positive or ptc+g greater than or equal to 2 * presence of donor specific antibody (dsa) * interstitial fibrosis and tubular atrophy (ifta) less than or equal to 2 * glomerular filtration rate \> 30 ml/min/1.73 m2 * signed informed consent to participate in the study exclusion criteria: * active infection or infection with hepatitis b, c or hiv virus * pregnant, breastfeeding or parturient woman * person deprived of liberty by judicial or administrative decision * person receiving psychiatric care under duress * person subject to legal protection * person out of state to express consent

Keywords: chronic antibody-mediated rejection extracorporeal phototherapy kidney transplantation
a study to characterize the disease behavior of idiopathic pulmonary fibrosis (ipf) and interstitial lung disease (ild) during the peri-diagnostic period

Conditions: Idiopathic Pulmonary Fibrosis; Interstitial Lung Disease

Summary: this international clinical study will enroll participants with a suspected diagnosis of ipf/ild. this study will characterize the disease behavior of ipf and ild in the peri-diagnostic period. this objective will be achieved using a multidimensional approach assessing changes in pulmonary function, measured by daily handheld spirometry and site spirometry as well as assessing physical functional capacity at home (accelerometry) and at site (6-minute walk tests \[6mwt\]). daily handheld spirometry or physical functional capacity assessments are not routinely performed in this participant population. by following participants' lung function before and after diagnosis using home spirometry, levels of physical activity, as well as self-assessment data from the participants (patient reported outcomes; pro), the study would provide potentially more rapid information on disease behavior and eventually progression compared to usual clinic measurements that occur only every 3-6 months. by receiving data from daily handheld spirometry measurements, treating physicians may have an improved chance of detecting earlier and outside of hospital visits a decline in lung function that could potentially lead to improvements in both diagnosis and treatment for participants with ipf/ild.


Eligibility criteria:
inclusion criteria: * able to comply with the study protocol, in the investigator's judgment - for example, the ability to use the provided spirometer and tablet and the ability to fill in the required patient reported outcomes questionnaires * suspicion of ipf/ild: radiological evidence of ipf/ild in symptomatic participants (unexplained dyspnea on exertion and/or cough) exclusion criteria: * participation in any investigational study within 28 days prior to inclusion * history of clinically significant cardiac disease that could explain the patient's symptomatology in the opinion of the investigator * known history of any connective tissue disease, including, but not limited to, rheumatoid arthritis, scleroderma, systemic lupus erythematosus, or mixed connective tissue disease
no-touch rfa versus traditional rfa for small hepatocellular carcinoma

Conditions: Hepatocellular Carcinoma

Summary: traditional rfa treatment has been a curable therapy for small hepatocellular carcinoma (diameter≤3cm). this technique ablates the tumor via radio frequency by inserting an electrode needle directly into the tumor. this clearly violates no-touch technique based on the principle of surgical oncology. thus the 1-year recurrence rate of the cancer is up to 30% after the treatment, and the 3-year tumor-free survival rate is only 20% - 40%. no-touch rfa treatment avoids the direct contact with the tumor that can cause the spread of cancer cells in the liver, or the antrim spread, therefore it has been suggested that no-touch rfa treatment reduce the recurrence rate after operation in comparison with the traditional rfa treatment. this research project aims at using the prospective randomized comparative method to compare the short-term and the long-term curative effects between no-touch rfa and traditional rfa treatments for small hepatic carcinoma.


Eligibility criteria:
inclusion criteria: 1. primary hepatocellular carcinoma, according to the postoperative pathological examination as the standard, or the diagnostic criteria with reference to the 2012 american association for the study of liver diseases if the pathological evidence is not available; 2. a single tumor with a diameter ≤3cm; 3. the tumor that has not invaded the portal vein, the hepatic vein, or the secondary branch; 4. liver function classified as child a or b; 5. liver reserve function test with icg-r15 (indocyanine green retention at 15min) ≤30%, and the important organs that can function with the tolerance of rfa or partial hepatectomy; 6. no significant coagulopathy: platelet count \> 50,000,000,000 /l, prolonged prothrombin time \< 5 seconds; 7. age 18 - 70 years old; 8. no acceptance of other anti-cancer therapy before the treatment. exclusion criteria: 1. complication of severe portal hypertension: a history of upper gastrointestinal bleeding, a history of severe hypersplenism, or refractory ascites; 2. patients with extrahepatic metastasis or lymph node metastasis; 3. patients with multiple liver tumors found from imaging exam or during the treatment; 4. patients with pathological examinations showing the other tissue type of liver cancer after the treatment; 5. patients who expect to receive a liver transplant; 6. patients whose preoperative imaging exam indicates the tumor close to the gallbladder, hilar major blood vessels, bile ducts and surrounding vital organs, with a potential of serious injury by mistake or serious complications during the treatment.

Keywords: small hepatocellular carcinoma no-touch rfa traditional rfa recurrence rate
physiological role of kiss-1/gpr54 system in the human ovary

Conditions: Infertility

Summary: the aim of this project is to study the physiological role of the kiss-1/gpr54 system in the granulosa cells of the human ovary.


Eligibility criteria:
inclusion criteria: * consenting oocyte donors exclusion criteria: -